Trial Outcomes & Findings for Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis , (NCT NCT01526889)
NCT ID: NCT01526889
Last Updated: 2021-01-05
Results Overview
Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Day 85 (end of study)
Results posted on
2021-01-05
Participant Flow
Approximately 24 patients were planned to be enrolled. A total of 25 patients were randomized (18 patients in LFG316 group and 7 patients in conventional therapy group).
Participant milestones
| Measure |
LFG316
LFG316 administered intravitreally
|
Conventional Therapy
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Treatment Period
STARTED
|
18
|
7
|
|
Treatment Period
COMPLETED
|
16
|
7
|
|
Treatment Period
NOT COMPLETED
|
2
|
0
|
|
Treatment Extension Period
STARTED
|
5
|
0
|
|
Treatment Extension Period
COMPLETED
|
4
|
0
|
|
Treatment Extension Period
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
LFG316
LFG316 administered intravitreally
|
Conventional Therapy
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Treatment Period
Adverse Event
|
2
|
0
|
|
Treatment Extension Period
Administrative problems
|
1
|
0
|
Baseline Characteristics
SAS
Baseline characteristics by cohort
| Measure |
LFG316
n=18 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=7 Participants
Conventional treatment was selected by the investigator
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 Years
STANDARD_DEVIATION 14.84 • n=5 Participants • SAS
|
39.1 Years
STANDARD_DEVIATION 14.89 • n=7 Participants • SAS
|
43.6 Years
STANDARD_DEVIATION 14.81 • n=5 Participants • SAS
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants • SAS
|
4 Participants
n=7 Participants • SAS
|
11 Participants
n=5 Participants • SAS
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants • SAS
|
3 Participants
n=7 Participants • SAS
|
14 Participants
n=5 Participants • SAS
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants • Safetyanalysis set
|
0 Participants
n=7 Participants • Safetyanalysis set
|
2 Participants
n=5 Participants • Safetyanalysis set
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants • Safetyanalysis set
|
7 Participants
n=7 Participants • Safetyanalysis set
|
23 Participants
n=5 Participants • Safetyanalysis set
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Safetyanalysis set
|
0 Participants
n=7 Participants • Safetyanalysis set
|
0 Participants
n=5 Participants • Safetyanalysis set
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=5 Participants • SAS
|
6 Participants
n=7 Participants • SAS
|
23 Participants
n=5 Participants • SAS
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants • SAS
|
1 Participants
n=7 Participants • SAS
|
2 Participants
n=5 Participants • SAS
|
PRIMARY outcome
Timeframe: Day 85 (end of study)Population: Efficacy 1 analysis set: All patients in the safety analysis set who received any study treatment (LFG316 or conventional treatment) with evaluable efficacy data for at least one efficacy endpoint(s) (ocular assessments) and with no major protocol deviations that had an impact on efficacy data.
Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator
Outcome measures
| Measure |
LFG316
n=18 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=7 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye
Improvement of vitreous haze ≥2 steps (N=15,6)
|
3 Participants
|
3 Participants
|
|
Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye
Improvement of VA ≥ 10 letters (N=15,6)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye
Improvement of ACC score ≥2 steps (N=7, 1)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye
Resolution of chorioretinal lesions (N= 3, 0)
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 85 (end of study)Population: Efficacy 1 analysis set
Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial.
Outcome measures
| Measure |
LFG316
n=18 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=7 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Number of Participants With Remission in Study Eye - Treatment Period
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)Population: Efficacy 1 analysis set
Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+ Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed.
Outcome measures
| Measure |
LFG316
n=18 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=7 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 85 (end of study) · 4+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 2 · 0
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 2 · 0.5/Trace
|
2 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 2 · 1+
|
10 Participants
|
4 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 2 · 2+
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 2 · 3+
|
2 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 2 · 4+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 8 · 0
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 8 · 0.5/Trace
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 8 · 1+
|
4 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 8 · 2+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 8 · 3+
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 8 · 4+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 15 · 0
|
2 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 15 · 0.5/Trace
|
3 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 15 · 1+
|
6 Participants
|
4 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 15 · 2+
|
3 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 15 · 3+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 15 · 4+
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 29 · 0
|
0 Participants
|
3 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 29 · 0.5/Trace
|
4 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 29 · 1+
|
10 Participants
|
3 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 29 · 2+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 29 · 3+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 29 · 4+
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 43 · 0
|
6 Participants
|
2 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 43 · 0.5/Trace
|
1 Participants
|
3 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 43 · 1+
|
6 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 43 · 2+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 43 · 3+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 43 · 4+
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 57 · 0
|
5 Participants
|
2 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 57 · 0.5/Trace
|
5 Participants
|
2 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 57 · 1+
|
4 Participants
|
3 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 57 · 2+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 57 · 3+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 57 · 4+
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 85 (end of study) · 0
|
2 Participants
|
1 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 85 (end of study) · 0.5/Trace
|
6 Participants
|
3 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 85 (end of study) · 1+
|
3 Participants
|
2 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 85 (end of study) · 2+
|
3 Participants
|
0 Participants
|
|
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Day 85 (end of study) · 3+
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)Population: Efficacy 1 analysis set
Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions. ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded. BCVA is based on the number of letters read correctly.
Outcome measures
| Measure |
LFG316
n=18 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=7 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Day 2
|
72.5 letters
Standard Deviation 19.36
|
76.1 letters
Standard Deviation 0.7
|
|
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Day 8
|
80.5 letters
Standard Deviation 11.69
|
79.0 letters
Standard Deviation 79
|
|
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Day 15
|
68.8 letters
Standard Deviation 18.53
|
78.9 letters
Standard Deviation 9.10
|
|
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Day 29
|
70.3 letters
Standard Deviation 19.39
|
79.6 letters
Standard Deviation 9.47
|
|
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Day 43
|
65.5 letters
Standard Deviation 24.45
|
77.3 letters
Standard Deviation 9.07
|
|
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Day 57
|
72.6 letters
Standard Deviation 14.79
|
80.1 letters
Standard Deviation 10.35
|
|
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Day 85
|
72.1 letters
Standard Deviation 15.53
|
76.7 letters
Standard Deviation 10.25
|
SECONDARY outcome
Timeframe: Day 85 (end of study)Population: Efficacy 1 analysis set
Macular edema is a sign of uveitis.
Outcome measures
| Measure |
LFG316
n=10 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=3 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Number of Patients With Macular Edema in Study Eye - Treatment Period
Day 57
|
2 Participants
|
0 Participants
|
|
Number of Patients With Macular Edema in Study Eye - Treatment Period
Day 2
|
2 Participants
|
1 Participants
|
|
Number of Patients With Macular Edema in Study Eye - Treatment Period
Day 8
|
1 Participants
|
1 Participants
|
|
Number of Patients With Macular Edema in Study Eye - Treatment Period
Day 15
|
3 Participants
|
0 Participants
|
|
Number of Patients With Macular Edema in Study Eye - Treatment Period
Day 29
|
2 Participants
|
0 Participants
|
|
Number of Patients With Macular Edema in Study Eye - Treatment Period
Day 43
|
2 Participants
|
0 Participants
|
|
Number of Patients With Macular Edema in Study Eye - Treatment Period
Day 85 (end of study)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)Population: Efficacy 1 analysis set
Chorioretinal lesions is a sign of uveitis.
Outcome measures
| Measure |
LFG316
n=10 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=3 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Day 2
|
3 Participants
|
0 Participants
|
|
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Day 8
|
2 Participants
|
0 Participants
|
|
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Day 15
|
4 Participants
|
0 Participants
|
|
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Day 29
|
5 Participants
|
0 Participants
|
|
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Day 43
|
4 Participants
|
0 Participants
|
|
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Day 57
|
5 Participants
|
1 Participants
|
|
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Day 85 (end of study)
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)Population: Efficacy 1 analysis set
anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (\>50 aqueous cells).
Outcome measures
| Measure |
LFG316
n=10 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=3 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 2 · 0; <1 cell
|
2 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 2 · 0.5; 1-5 cells
|
4 Participants
|
1 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 2 · 1; 6-15 cells
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 2 · 2; 16-25 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 2 · 3; 26-50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 2 · 4; >50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 8 · 0; <1 cell
|
2 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 8 · 0.5; 1-5 cells
|
4 Participants
|
1 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 8 · 1; 6-15 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 8 · 2; 16-25 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 8 · 3; 26-50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 8 · 4; >50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 15 · 0; <1 cell
|
3 Participants
|
1 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 15 · 0.5; 1-5 cells
|
4 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 15 · 1; 6-15 cells
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 15 · 2; 16-25 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 15 · 3; 26-50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 15 · 4; >50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 29 · 0; <1 cell
|
2 Participants
|
1 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 29 · 0.5; 1-5 cells
|
5 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 29 · 1; 6-15 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 29 · 2; 16-25 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 29 · 3; 26-50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 29 · 4; >50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 43 · 0; <1 cell
|
5 Participants
|
1 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 43 · 0.5; 1-5 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 43 · 1; 6-15 cells
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 43 · 2; 16-25 cells
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 43 · 3; 26-50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 43 · 4; >50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 57 · 0; <1 cell
|
5 Participants
|
1 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 57 · 0.5; 1-5 cells
|
1 Participants
|
1 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 57 · 1; 6-15 cells
|
2 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 57 · 2; 16-25 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 57 · 3; 26-50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 57 · 4; >50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 85 · 0; <1 cell
|
4 Participants
|
3 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 85 · 0.5; 1-5 cells
|
5 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 85 · 1; 6-15 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 85 · 2; 16-25 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 85 · 3; 26-50 cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Day 85 · 4; >50 cells
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Throughout the study (treatment and extension period), up to day 271Population: Pharmacokinetic analysis set: All patients in the safety analysis set with evaluable PK data and with no protocol deviations affecting PK data.
Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies \[anti-drug antibodies\]). NO: No immunogenicity; YES: Positive immunogenicity.
Outcome measures
| Measure |
LFG316
n=17 Participants
LFG316 administered intravitreally
|
Conventional Therapy
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 1 · participants with anti-LFG316 antibodies
|
3 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 1 · participants without anti-LFG316 antibodies
|
12 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 29 · participants with anti-LFG316 antibodies
|
3 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 29 · participants without anti-LFG316 antibodies
|
10 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 85 (end of study) · participants with anti-LFG316 antibodies
|
2 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 85 (end of study) · participants without anti-LFG316 antibodies
|
9 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 169 · participants with anti-LFG316 antibodies
|
1 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 169 · participants without anti-LFG316 antibodies
|
1 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 253 · participants with anti-LFG316 antibodies
|
0 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
Day 253 · participants without anti-LFG316 antibodies
|
1 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
End of extension period · participants with anti-LFG316 antibodies
|
1 Participants
|
—
|
|
Number of Participants With or Without Anti-LFG316 Antibodies
End of extension period · participants without anti-LFG316 antibodies
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2, 15, 29, 43, 57 and, 85 (end of the study)Population: Pharmacodynamic (PD) analysis set: All patients in the safety analysis set with EVALUABLE pharmacodynamics (PD) data (Total C5) and with no major protocol deviations that had an impact on PD data were included in the PD analysis set.
Percent change from baseline (using each patient's pre-dose value as baseline) in total C5 concentrations.
Outcome measures
| Measure |
LFG316
n=15 Participants
LFG316 administered intravitreally
|
Conventional Therapy
n=7 Participants
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Day 2
|
6.80 Percent change in C5
Standard Deviation 14.5
|
1.02 Percent change in C5
Standard Deviation 5.69
|
|
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Day 15
|
8.21 Percent change in C5
Standard Deviation 15.3
|
-1.27 Percent change in C5
Standard Deviation 19.7
|
|
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Day 29
|
10.6 Percent change in C5
Standard Deviation 17.4
|
-8.33 Percent change in C5
Standard Deviation 17.5
|
|
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Day 43
|
8.38 Percent change in C5
Standard Deviation 13.4
|
6.46 Percent change in C5
Standard Deviation 18.6
|
|
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Day 57
|
6.73 Percent change in C5
Standard Deviation 12.0
|
5.98 Percent change in C5
Standard Deviation 40.9
|
|
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Day 85
|
3.21 Percent change in C5
Standard Deviation 22.1
|
1.28 Percent change in C5
Standard Deviation 31.3
|
Adverse Events
LFG316
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Conventional Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LFG316
n=18 participants at risk
LF G316 administered intravitreally
|
Conventional Therapy
n=7 participants at risk
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Eye disorders
Retinal detachment
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Retinopathy proliferative
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Mycotic endophthalmitis
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
Other adverse events
| Measure |
LFG316
n=18 participants at risk
LF G316 administered intravitreally
|
Conventional Therapy
n=7 participants at risk
Conventional treatment was selected by the investigator
|
|---|---|---|
|
Eye disorders
Cataract
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Conjunctival haemorrhage
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Conjunctival hyperaemia
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Cystoid macular oedema
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Macular fibrosis
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Uveitis
|
22.2%
4/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Visual impairment
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Eye disorders
Vitreous floaters
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Immune system disorders
Hypersensitivity
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Giardiasis
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Investigations
Blood pressure increased
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Investigations
Intraocular pressure increased
|
16.7%
3/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Investigations
Optic nerve cup/disc ratio increased
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
0.00%
0/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
14.3%
1/7 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER